Comparison of propofol and sevoflurane with and without remifentanil on anesthesia depth and hemodynamic stability
Design
four parallel groups ,randomised ,two tail blinded with 100 patients
Settings and conduct
In this study 100 patients who are going to have a laparoscopic cholecystectomy would be included.patients with age if 15 to 65,without history of addiction and with BMI less than 30 would enter the study. The anesthesiologyst who manages anesthesia would perform anesthesia on the clinical situation of patient and without any information about bis values. Bis value and MAP and HR would be recorded every 5 minutes. The time betwean drug cessation and opening eyes of patient and severity of patient’ pain also would be recorded. As mentioned before,the anesthsiologist who manages anesthesia do not have any information about bid values and manages anesthesia according to patients clinical situation.
Participants/Inclusion and exclusion criteria
age betwean 15 and 65
BMI less than 30
without history of addiction
Intervention groups
propofol
propofol and remifentanil
sevofluran
sevofluran and remifentanil
Main outcome variables
1-Mean bis values indicating anesthesia deepness when sevofluran with or without remifentanil is used in comparrison with propofol.
2-Mean arterial pressure and heart rate change when sevofluran or propofol is used with or without remifentanil.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210309050653N1
Registration date:2022-05-25, 1401/03/04
Registration timing:retrospective
Last update:2022-05-25, 1401/03/04
Update count:0
Registration date
2022-05-25, 1401/03/04
Registrant information
Name
elyas naghib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4483 5090
Email address
naghib.e@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of propofol and sevoflurane with and without remifentanil on anesthesia depth and hemodynamic stability
Public title
Comparison of propofol and sevoflurane with and without remifentanil on anesthesia depth and hemodynamic stability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with age og 15 to 65 years old
GCS of 15
Exclusion criteria:
history of addiction
BMI more than 30
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
selection of samples will be with available sampling and attribution of patients to the groups will be done with random allocation software.80 patients who are going to have choleystectomy surgery according to main and inclusion criteria will be considered.patients will be claassified to four group with random allocation software.And it would be clarified that number one or number ten patient should be in which one of these groups and which drug they should recieve.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients are not aware of type of anesthesia drugs.and the anesthesiologist who manages aneshesia is not aware of BIS values and he manages depth of anesthesia according to his clinical experience
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Intervention group: patients who recieve sevofluran as a maintenance anesthetic drug.In this group,patients will recieve sevofluran with the dose of almost 3 MAC.The anesthesiologyst may change the dose of sevofluran according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values.
Category
Treatment - Drugs
2
Description
Intervention group: patients who recieve sevofluran as a maintenance anesthetic drug.In this group,patients will recieve sevofluran with the dose of almost 3 MAC and remifentanil with the dose of 0.2 microgran/kg/min.The anesthesiologyst may change the dose of sevofluran and remifentanil according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values.
Category
Treatment - Drugs
3
Description
Intervention group: patients who recieve propofol as a maintenance anesthetic drug.In this group,patients will recieve propofol with the dose of 150 microgram/kg/min.The anesthesiologyst may change the dose of propofol according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values.
Category
Treatment - Drugs
4
Description
Intervention group: patients who recieve propofol and remifentanil as a maintenance anesthetic drug.In this group,patients will recieve propofol with the dose of 150 microgram/kg/min and remifentanil with the dose of 0.2 microgran/kg/min .The anesthesiologyst may change the dose of propofol and remifentanil according to the patients medical condition without knowing the BIS value.The Danmeter DK-5000 device will be used for recording of BIS values.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Elyas Naghib
Street address
Parastar street,Hafez bulvard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
elyasnaghib@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Massumeh Moezzi
Street address
Parastar street,Hafez bulvard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
elyasnaghib@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elyas Naghib
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street,Hafez bulvard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
elyasnaghib@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street,Hafez bulvard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
hosseinmadineh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elyas Naghib
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street,Hafez bulvard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
elyasnaghib@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
some parts of data could be shared.
When the data will become available and for how long
since 1402
To whom data/document is available
university researchers
Under which criteria data/document could be used
similar research subject
From where data/document is obtainable
Elyas Naghib
What processes are involved for a request to access data/document